MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE INTEGRITY RX; STENT, CORONARY, DRUG-ELUTING

Catalog Number	RSINT35038UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 1st, 2nd, 3rd, 15th and 16th distal stent wraps with struts raised, bunched and overlapping.No deformation was evident to the distal tip.The inner lumen patency was verified.(b)(4).
Event or Problem Description
It was reported that the physician intended to use a resolute integrity rx drug eluting stent to treat a lesion located at the right coronary artery.There were there no abnormalities reported in relation to anatomy.There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray.No difficulties were noted during the removal of the protective sheath and during the removal of the packaging stylette.The device was inspected with no issues noted.Negative prep was not performed.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device and excessive force was not used during delivery.It was reported that there was a kink at the tip of the catheter/delivery system.The tip damage was first noted when the physician went to deliver the stent and loaded it onto the guide wire; the device was inserted into the patient.Patient status post-procedure is alive with no injury.Deformation of stent was noted during analysis.Device analysis showed that the distal end of the stent was damaged and the account has confirmed that was initially referred to as the tip of the catheter/delivery system.

• Brand Name: RESOLUTE INTEGRITY RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7178295
• Report Number: 9612164-2018-00049
• Device Sequence Number: 1066637
• Product Code: NIQ
• UDI-Device Identifier: 00643169037298
• UDI-Public: 00643169037298
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2019
• Device Catalogue Number: RSINT35038UX
• Device Lot Number: 0008620559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 103